NCT06386588 The Effects of Auditory Stimulation During Sleep on Brain Networks in Schizophrenia
| NCT ID | NCT06386588 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-02-05 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-02-05 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In this research study the investigators will use sleep headbands to measure brain rhythms and to improve their coordination across brain regions. The headbands will be worn at home for multiple nights. On some nights the headbands will play soft sounds at specific times during sleep. The investigators are interested in learning whether this timed auditory stimulation may be a strategy to improve the coordination of sleep rhythms across brain regions, improve network communication, and as a result, improve memory. The investigators will study 30 adults aged 18-45 with schizophrenia and 30 demographically matched healthy controls. Participants will first have a daytime MRI scan, during which they will complete a finger tapping motor sequence task (MST), followed by a week of sleep at home with a sleep headband. They will also do the MST at home on two of the nights. On the final day of the study, participants will return for a second MRI scan.
Eligibility Criteria
Inclusion Criteria: * 18-45 years old * Fluent in English * Able to give informed consent Additional inclusion for Adults with schizophrenia: * A DSM-V confirmed diagnosis of schizophrenia * Unmedicated or maintained on a stable dose of APDs Exclusion Criteria: * Ferrous metal in the body * Currently pregnant or breastfeeding * Motor problems that preclude finger tapping task * IQ \<85 * Other neurological disorders, including seizure disorder * Significant hearing or vision loss * Chronic medical conditions that affect sleep * Unstable chronic medical condition such as asthma, diabetes, cystic fibrosis, or cardiac disease * Diagnosed sleep disorder, except insomnia * History of head injury resulting in prolonged loss of consciousness or other neurological sequelae Additional Exclusion Criteria for Healthy adults: * History of mental illness * Current use of psychotropic medications or treatment with medications known to affect sleep or cognition
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06386588 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06386588 currently recruiting?
Yes, NCT06386588 is actively recruiting participants. Contact the research team at manoachlab@gmail.com for enrollment information.
Where is the NCT06386588 trial being conducted?
This trial is being conducted at Charlestown, United States.
Who is sponsoring the NCT06386588 clinical trial?
NCT06386588 is sponsored by Massachusetts General Hospital. The trial plans to enroll 60 participants.
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